A clinician examining a mammogram

Around 5,700 people with early breast cancer are set to benefit from expanded access to a treatment combination designed to help prevent their cancer from returning, following our recommendation, published today. 

Our final draft guidance approves ribociclib (brand name Kisqali), made by Novartis, combined with an aromatase inhibitor as an additional treatment option for hormone receptor-positive, HER2-negative early breast cancer that has responded to initial treatments including surgery, but where there is a higher risk of the cancer returning. 

Today's decision significantly expands access to the treatment, which was previously available only for people whose cancer had spread to nearby lymph nodes. The new recommendation means it will now also be available for people whose disease hasn't spread to nearby lymph nodes. 

Milestone for breast cancer care 

The approval means ribociclib becomes the 25th out of 26 breast cancer treatments that NICE has recommended for NHS use in the last seven years. 

This is fantastic news for the tens of thousands of patients and their loved ones who are now benefiting from access to cutting edge new treatments.

It is also due in no small part to the willingness of companies to engage with us constructively, as in the case with ribociclib, to ensure the benefits of their treatments are properly presented and appropriately priced

How the treatment works 

Ribociclib is a targeted therapy that works by blocking proteins called cyclin-dependent kinase (CDK) 4 and 6, which play a crucial role in cancer cell growth and division. By inhibiting these proteins, the treatment helps to slow or stop cancer growth. 

The drug is taken alongside an aromatase inhibitor, a hormone therapy that reduces oestrogen levels in the body. Clinical trials have shown this combination approach may extend the time before cancer returns compared with using an aromatase inhibitor alone. 

Longer remission periods 

Clinical trial evidence demonstrates that combining ribociclib with an aromatase inhibitor may extend the time before cancer returns compared with using an aromatase inhibitor alone. This represents a significant advance for patients with hormone receptor-positive, HER2-negative early breast cancer, offering them enhanced protection during the critical period following initial treatment. 

The treatment has been made cost-effective for the NHS through a confidential discount agreement with Novartis, ensuring patients can access this innovative therapy while maintaining value for the health service. 

NICE already recommends ribociclib in combination with fulvestrant for treating hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer in adults who have had previous endocrine therapy, demonstrating the drug's versatility across different stages of the disease. 

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